Profile: Germaine Laboratories, Inc. manufactures & supplies medical diagnostic tests for professional use, point-of-care and over-the-counter consumer use. We offer FDA regulatory consultation and 510k clinical trials.

The company is ISO 13485:2003 certified.

FDA Registration Number: 1649661

51 to 56 of 56 Products/Services (Click for related suppliers)  Page: 1 [2]

• Urinary Nitrite Colorimetric Test (FDA Code: JMT / 862.1510) A nitrite (nonquantitative) test system is a device intended to identify nitrite in urine. Nitrite identification is used in the diagnosis and treatment of uninary tract infection of bacterial origin.

• Urinary pH Dye Indicator (FDA Code: CEN / 862.1550) A urinary pH (nonquantitative) test system is a device intended to estimate the pH of urine. Estimations of pH are used to evaluate the acidity or alkalinity of urine as it relates to numerous renal and metabolic disorders and in the monitoring of patients with certain diets.

• Urinary Protein/Albumin Nonquantitative Test System (FDA Code: JIR / 862.1645) A urinary protein or albumin (nonquantitative) test system is a device intended to identify proteins or albumin in urine. Identification of urinary protein or albumin (nonquantitative) is used in the diagnosis and treatment of disease conditions such as renal or heart diseases or thyroid disorders, which are characterized by proteinuria or albuminuria.

• Urine Laboratory Testing

• Urine Leukocyte Test (FDA Code: LJX / 864.7675) A leukocyte peroxidase test is a device used to distinguish certain myeloid cells derived from the bone marrow, i.e., neutrophils, eosinophils, and monocytes, from lymphoid cells of the lymphatic system and erythroid cells of the red blood cell series on the basis of their peroxidase activity as evidenced by staining. The results of this test are used in the differential diagnosis of the leukemias.

• Urine Specimen Collection Cups